Emergency vessel repair prosthesis deployment system

ABSTRACT

A deployment device to deploy a prosthesis for interconnecting vessel portions of a body vessel is described herein. The device includes a support frame and an actuation member coupled to the support frame. The actuation member is movable between a first and a second position. A retaining member is movable between a closed and a open position. In the closed position, the retaining member forms a chamber to retain a length of a prosthesis in a compressed configuration. In the open position, the retaining member is positioned to allow the prosthesis to move to an expanded configuration. Movement of the actuation member to the second position causes movement of the retaining member to the open position. One or more retractable cuffs can be positioned over the ends of the prosthesis for selectively retaining the corresponding prosthesis ends in the compressed configuration.

RELATED APPLICATION

The present patent document claims the benefit of the filing date under35 U.S.C. §119(e) of Provisional U.S. patent application Ser. No.61/526,048, filed Aug. 22, 2011, which is hereby incorporated byreference.

BACKGROUND

The present disclosure relates generally to medical devices. Moreparticularly, it relates to deployment systems used for repairingdamaged body vessels and gaining hemostasis during emergency medicalprocedures.

Trauma physicians frequently encounter patients having traumatic injuryto a body vessel, such as lacerated vessels or even transected vessels,resulting from gunshots, knife wounds, motor vehicle accidents,explosions, etc. Significant damage to a body vessel may expose apatient to deleterious conditions such as the loss of a limb, loss offunction of a limb, increased risk of stroke, impairment of neurologicalfunctions, and compartment syndrome, among others. Particularly severecases of vascular injury and blood loss may even result in death. Insuch severe situations, the immediate goal is to obtain hemostasis whilemaintaining perfusion of adequate blood flow to critical organs, such asthe brain, liver, kidneys, and heart.

Examples of treatment that are commonly performed by trauma physiciansto treat body vessel injuries include the clamping of the vessel with ahemostat, the use of a balloon tamponade, the ligation of the damagedvessel at or near the site of injury, or the insertion of one or moretemporary shunts. However, conventional surgical repair is generallydifficult with such actively bleeding, moribund patients. In manyinstances, there is simply not enough time to repair the body vesseladequately by re-approximating and suturing the body vessel. In manysituations, the trauma physician will simply insert a temporary shunt(such as a Pruitt-Inahara Shunt) into the vessel. However, use oftemporary shunts has been linked to the formation of clots. This mayrequire returning the patient to the operating room for treatment andremoval of the clots, often within about 36 to 48 hours of the originalrepair. Since shunts are generally placed as a temporary measure torestore blood flow and stop excessive blood loss, the shunt is typicallyremoved when the patient has stabilized (generally a few days later) bya specialized vascular surgeon. After removal, the vascular surgeon willreplace the shunt with a vascular graft, such as a fabric graft that issewn into place. With respect to ligation, ligation of the damaged bloodvessel may result in muscle necrosis, loss of muscle function, or apotential limb loss or death.

Due to the nature of the body vessel injury that may be encountered, theinsertion of shunts or ligation of a blood vessel, for example, oftenrequires that such treatments be rapidly performed at great speed, andwith a high degree of physician skill. Such treatments may occupy anundue amount of time and attention of the trauma physician at a timewhen other pressing issues regarding the patient's treatment requireimmediate attention. In addition, the level of particularized skillrequired to address a vascular trauma may exceed that possessed by thetypical trauma physician. In particular, traumatic episodes to thevessel may require the skills of a physician specially trained toaddress the particular vascular trauma, and to stabilize the patient inthe best manner possible under the circumstances of the case.

Some open surgical techniques utilize sutures to affix damaged tissueportions surrounding fittings that have been deployed with the vessel,which requires the trauma physician to take time to tie the suturesproperly. Although in modern medicine sutures can be tied in relativelyrapid fashion, any step in a repair process that occupies physician timein an emergency situation is potentially problematic. In addition, theuse of sutures to affix the vessel to the fitting compresses the tissueof the vessel against the fitting. Compression of tissue may increasethe risk of necrosis of the portion of the vessel tissue on the side ofthe suture remote from the blood supply. When present, necrosis of thisportion of the vessel tissue may result in the tissue separating at thepoint of the sutures. In this event, the connection between the vesseland the fitting may eventually become weakened and subject to failure.If the connection fails, the device may disengage from the vessel.Therefore, efforts continue to develop techniques that reduce thephysician time required for such techniques, so that this time can bespent on other potentially life-saving measures, and the blood flow ismore quickly restored and damage caused by lack of blood flow isminimized.

Trauma physicians generally find it difficult to manipulate a prosthesisfor insertion into a body vessel that has been traumatically injured.For example, one difficulty arises from the trauma physician trying tolimit the size of the opening created for gaining access to the injuredvessel so that such opening requiring healing is as small as possible.Another difficulty is that the injured vessel can be anywhere in thebody, having different surrounding environments of bone structure,muscle tissue, blood vessels, and the like, which makes suchobstructions difficult to predict in every situation and leaves thetrauma physician working with an even further limited access opening.Another potential consideration is the amount of body vessel removedduring a transection. The goal would be to remove a portion of the bodyvessel as small as possible. Yet, a small portion removed from thevessel leaves such a small space between the two vessel portions,thereby making it difficult to introduce the prosthesis between the twovessel portions.

Thus, what is needed is a deployment device for delivering a prosthesisfor use in repair of an injured body vessel, such as an artery or avein, (and in particular a transected vessel) during emergency surgery.It would be desirable if such deployment device was easy for a traumaphysician to use, and can rapidly introduce a prosthesis into two vesselportions of a transected vessel, thereby providing a conduit for bloodwithin the injured body vessel.

SUMMARY

Accordingly, various examples of deployment devices are provided hereinto address at least some of the shortcomings of the prior art. Thedeployment device can be used to connect a first vessel portion and asecond vessel portion of a body vessel such as, e.g., for open surgicalrepair of a body vessel. In one example, the device can include asupport frame and an actuation member coupled to the support frame. Theactuation member is movable between a first and a second position. Aretaining member, e.g., in the form of shells or clamps, is coupled tothe actuation member and/or the support member. The retaining member ismovable between a closed and an open position. In the closed position,the retaining member can form a chamber to retain a length of aprosthesis in a compressed configuration. In the open position, theretaining member is positioned to allow the prosthesis to move to anexpanded configuration. Movement of the actuation member to the secondposition causes movement of the retaining member to the open position.The device may include one or more retractable cuffs at the prosthesisends for selectively retaining the prosthesis ends in the compressedconfiguration.

In another example, the device can include a support frame and anactuation member coupled to the support frame. The actuation member ismovable relative to the support frame between a first position and asecond position. A first shell and a second shell can be coupled to thesupport frame. The shells are movable relative to one another between aclosed position and an open position. In the closed position, the firstshell and the second shell are positioned in close proximity to form aretaining chamber to retain at least an intermediate segment of aprosthesis in a radially compressed configuration. In the open position,the first shell and the second shell are positioned away from oneanother to allow the segment of the prosthesis to move to a radiallyexpanded configuration. The device can include retractable ends, such asa first and a second retractable cuff, coupled to the first and secondshells to selectively retain the first and second outer ends of theprosthesis in the radially compressed configuration. Movement of theactuation member from the first position to the second position causesthe first and second shells to move from the closed position to the openposition.

In yet another example, a method of treating a body vessel is describedherein. The method can include introducing a deployment system having aprosthesis within a body. The system can include a support frame and anactuation member coupled to the support frame. The actuation member ismovable relative to the support frame along a first axis between a firstposition and a second position. A retaining member is coupled to thesupport frame. The retaining member is movable between a closed positionand an open position. In the closed position, the retaining member canform a retaining chamber to retain at least an intermediate length ofthe prosthesis in the radially compressed configuration. The deploymentsystem is introduced with the actuation member in the first position andthe retaining member in the closed position. The first outer end of theprosthesis can be introduced into a first vessel portion. The secondouter end of the prosthesis can be introduced into a second vesselportion. The actuation member can be moved from the first position tothe second position to actuate the retaining member to move to an openposition. This movement can allow at least the intermediate length ofthe prosthesis to move to a radially expanded configuration in order forthe prosthesis to connect the first and second vessel portions together.Retractable ends can be moved inward to a position to permit expansionof the outer ends of the prosthesis prior to the moving the actuationmember.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a perspective view of one example of a deployment devicepre-loaded with a prosthesis.

FIG. 2 is a perspective view of an actuation member of the deploymentdevice of FIG. 1.

FIG. 3A is a perspective view of a retaining member of the deploymentdevice of FIG. 1.

FIG. 3B is a partial side view of the retaining member in a closedposition.

FIGS. 4A-4C are side views depicting operation of the deployment deviceof FIG. 1.

FIG. 5 is a perspective view of another example of a deployment devicepre-loaded with a prosthesis.

FIG. 6 is a perspective view of a retractable cuff coupled to thedeployment device of FIG. 5.

FIG. 7 is a transverse sectional view of the retractable cuff takenalong lines 7-7 in FIG. 5.

FIGS. 8A-8B are perspective views depicting operation of the retractablecuff of the deployment device of FIG. 5.

FIGS. 9A-9E illustrate a method of connecting body vessel portions withthe deployment device of FIG. 1 to treat a body vessel.

FIGS. 10A-10C illustrate a method of connecting body vessel portionswith the deployment device of FIG. 5 to treat a body vessel.

FIG. 11 is a perspective view of another example of a deployment device.

FIG. 12 is a front view of a distal end of the deployment device of FIG.11.

FIG. 13 is a cross sectional view of a distal end of the deploymentdevice taken along lines 12-12, depicting a retaining member in a closedposition.

FIG. 14 is a cross sectional view of a distal end of the deploymentdevice of FIG. 13, depicting a retaining member in an open position.

FIG. 15A is a perspective view of another example of a deploymentdevice, with a retaining member in the closed position.

FIG. 15B is a perspective view of the deployment device of FIG. 15A,with the retaining member in the open position.

FIG. 16 is a perspective view of the deployment device of FIG. 15A, withthe bottom half of the device removed.

FIGS. 17A-17D are perspective view of various aspects of one example ofretractable cuffs provided with the deployment device of FIG. 15A.

FIGS. 18-19 illustrate movement of a release member and a retractablecuff.

FIGS. 18A-19A are magnified views of a portion of the device shown inFIGS. 18-19, respectively, to depict the movement between the releasemember and the retractable cuff.

FIG. 20 is a partial perspective view of another example of a deploymentdevice with another embodiment of retractable cuffs.

FIG. 21 a perspective view of another example of a deployment device,with a retaining member in the closed position.

FIG. 22 is a cross-sectional view of a distal end of the deploymentdevice of FIG. 21, with the retaining member in the open position.

FIGS. 23A-B illustrate examples of an actuation member and a releasemember provided with the deployment device of FIG. 21.

FIGS. 24-25 are perspective views of a distal end of the deploymentdevice of FIG. 21, depicting one arrangement of a shell and a cuff.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It should nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated device, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to oneskilled in the art to which the invention relates. Throughout thespecification, when referring to a medical device, or a portion of amedical device, the terms “distal” and “distally” shall denote aposition, direction, or orientation that is generally towards, or in thedirection of, the patient when the device is in use. The terms“proximal” and “proximally” shall denote a position, direction, ororientation that is generally away from the patient, or closer to theoperator, during use of the device. It is understood thatlike-referenced numerals are used throughout the Figures to designatesimilar components.

The deployment devices described herein can be useful for repair of bodystructures or vessels that define lumens, ducts, or passageways, withthe term “body vessel” used in the specification to describe thesesstructures in general, during emergency open surgical repair. In oneexample, the prosthesis can be particularly useful for repair of alacerated or transected artery or vein during emergency open surgery,and particularly, to obtain hemostasis or fluid stability whilemaintaining blood perfusion or fluid flow. While some prosthetic devicesare only implanted temporarily for treatment, the prosthesis can beimplanted permanently thereby obviating the need for further surgicalintervention and repair.

Such devices are typically inserted through a trauma pathway that isformed in the body to gain access to the desired body vessel. The traumapathway can be oblique, and on occasion perpendicular, to the desiredbody vessel, and is formed as small as possible to minimize any furtherdamage to the body. To this end, the device can have an elongated bodyto minimize the cross-section relative to the cross-section of thetrauma pathway and a length suitable to extend from the desired bodyvessel and out in a manner to allow the end user to operate the device.This can allow the end user to operate the device from the proximal endand deliver the prosthesis from the distal end. The device can include asupport frame and an actuation member coupled to the support frame. Theactuation member is movable to open and close a retaining member. In theclosed position, the retaining member can form a chamber to retain atleast a length of a prosthesis in a radially compressed configuration.In the open position, the retaining member is positioned to allow theprosthesis to move to a radially expanded configuration. The device mayinclude retractable ends over the prosthesis ends for selectivelyretaining the outer ends in the compressed configuration. The variousdevices described herein have different arrangements of the actuationmember, the retaining member, and the retractable ends, if employed.

FIG. 1 depicts one embodiment of a deployment device 10 having a handleportion 12 and a retaining member 14 that can retain a prosthesis 15 ina radially compressed configuration. The retaining member 14 is movablebetween a closed position, whereby at least a length of the prosthesis15 is in the radially compressed configuration, and an open position,whereby the prosthesis 15 is permitted to move to a radially expandedconfiguration. The handle portion 12 can include an actuation member 16coupled to a support frame 18. The actuation member 16 is configured tomove relative to support frame 18 between a first position and a secondposition. When the actuation member 16 is in the first position, theretaining member 14 is in the closed position, and while in the secondposition, the retaining member 14 is in the open position.

In FIGS. 1-2, the actuation member 16 can include a plunger 20, whichcan have a first or proximal portion 22, an intermediate body 24, and asecond or distal portion 26 coupled to one another. Support frame 18 caninclude a tubular body 30 that can have a proximal portion 32, anintermediate portion 34, and a distal portion 36 coupled to one another.Tubular body 30 can define a passageway 38 about a translational axis TAthat can extend through the proximal and distal portions of the tubularbody. The translational axis TA can be oblique or substantiallyperpendicular to a longitudinal axis LA of the prosthesis. Thepassageway 38 is sized to receive the elongated body 24 of the plungerso that the plunger is capable of being translated along thetranslational axis between a first position and a second position. Thepassageway 38 can include additional features, such as bearings and/orlubrication, to facilitate translation of the plunger.

The proximal portion 22 of the plunger 20 can extend proximally beyondthe proximal portion 32 of the support frame 18, and the distal portion26 of the plunger can extend distally beyond the distal portion 36 ofthe support frame. The proximal portion 22 of the plunger can be anenlarged member having a cross-section that is larger than thecross-section of the passageway 38. In FIG. 2, a proximal surface 40 ofthe proximal portion 22 can be planar and may be provided with surfaceirregularities, such as grooves, dimples, protrusions, or the like,formed in the surface 40 to improve grippability for the end user. Thedistal portion 26 can be elongated body that can generally extendoblique or substantially perpendicular to the translational axis TA,which may be substantially parallel to the longitudinal axis LA of theprosthesis. A distal end of the intermediate body 24 can be coupled toapproximately the center portion of a proximal surface 27 of the distalportion 26. A distal surface 28 of the distal portion 26 may becontoured to have an increasingly smaller cross-sectional area towardthe distal direction, such as rounded or wedged, to engage the shells60, 62 of the retaining member 14, as will be explained. In one example,the distal portion 26 is a semi-cylindrical body.

The proximal portion 32 of the tubular body 30 of the support frame 18can extend radially outward from the passageway 38 to define a grippingflange 42. The proximal portion 32 can be rounded and generally extendperpendicular to the translational axis TA. The cross-section of thegripping flange 42 may be larger than the cross-section of the proximalportion 22 of the plunger. The gripping flange 42 may have an outer edge44 which may be rounded for facilitating handability for the end user.The distal portion 36 of the tubular body 30 of the support frame 18 canbe axially spaced from the proximal portion 32 of the support frame bythe axial length of the intermediate body 34. The distal portion 36 canhave a variety of geometric shapes. For example, the distal portion 36can be a plate 46 with a rectangular shape having longer sides that areoriented along the same direction of the longitudinal axis LA of theprosthesis. The distal portion 36 can generally extend perpendicular tothe translational axis TA. A pair of walls 48 may depend from a distalsurface of the plate 46. The walls 48 can extend along the longer sidesof the plate 46. Each of walls 48 may have a notch 50 formed therein toform a first hinge segment 51. A pin 52 can extend from an end portionof the first hinge segment 51 within the region of the notch 50 andalong the general direction of the wall 48 to form a part of a hinge aswill be explained. An inner groove 54 can be formed in the distalsurface of the plate 46 along an inner side of the each of the walls 48.

The retaining member 14 can include a first shell 60 and a second shell62 that together are configured to define a prosthesis retaining chamber64 about the longitudinal axis LA when the retaining member is in theclosed position, as shown in FIG. 1. FIG. 3A depicts an example of thefirst shell 60, with the second shell 62 being a mirror image of thefirst shell 60. Each of the shells can include a proximal portion 66 anda distal portion 68. The distal portion 68 can be shaped such that whenthe shells are in the closed position, the distal portion 68 forms atubular chamber. In one example, a longitudinal recess 70 can be formedin a confronting surface 71 of the shell along the distal portion 68.The recess 70 can have a semi-circular cross-section, but othergeometric cross-sections may be used so long as the recess is configuredto receive at least about half of the prosthesis. Each recess 70 isconfigured so that when the shells are in the closed position therecesses together form the prosthesis retaining chamber 64 for retainingthe prosthesis in the radially compressed configuration.

In FIG. 3A, the proximal portion 66 can be a bi-angled surface includingan outer support surface 72 and an inner engaging surface 74 that iscontiguous with the confronting surface 71. The outer support surface 72can include a second hinge segment 76 configured to be coupled with thefirst hinge segment 51 of the support frame 18 with the pin 52 to form ahinged attachment 80 between the support frame 18 and the shells 60, 62,as shown in FIG. 1. The second hinge segment can be a cylindricaltubular member that is configured to receive the pin 52. As a result,the shells 60, 62 are capable of swinging inward and outward about thepivot axis formed by the hinged attachment 80 for movement of theretaining member 14 between the closed and open positions. The amount ofmaterial removed to form the notch 50 is sufficient to permit the hingedattachment 80 to be formed with the pin 52 and the second hinge segment76. The confronting surface 71 can be a substantially planar surface.The confronting surfaces 71 of the first and second shells 60, 62 mayengage one another when the shells are in the closed position to definea plane that is substantially coplanar with a plane defined by thetranslational and longitudinal axes TA, LA.

In FIG. 3B, the inner engaging surface 74 can be obliquely angled at afirst angle A1 relative to the plane defined by the translational andlongitudinal axes TA, LA, while the outer support surface 72 can beangled at a second angle A2. The first angle A1 can be configured sothat each the inner engaging surface 74 of the shells 60, 62 in theclosed position together form a retaining engaging surface 77 of theretaining member 14. The retaining engaging surface 77 can form aV-shape or a U-shape for slidable engagement with the distal portion 26of the plunger 20. To this end, the distal surface 28 of the distalportion 26 of the plunger can be configured to slidably engage theconverging or angled inner engaging surfaces 74 to allow for pivotabledisplacement of the shells 60, 62 outward about the respective pivotaxes formed by the hinged attachments.

In FIG. 1, the device can include one or more biasing members to biasthe shells 60, 62 in either the open or the closed position, butpreferably in the closed position. The biasing member 82 can be coupledbetween the support frame 18 and each of the shells 60, 62. In oneexample, the biasing member 82 is a helical torsion spring having a coil84 positioned within the inner groove 54 of the support frame 18, whilea first leg 86 is fixed in a secure relationship with the support frame18, and a second leg 88 is fixed in a secure relationship with each ofthe shells 60, 62. The outer support surface 72 may include a boreformed therein for receiving a length of the second leg 88 of thebiasing member. The legs 86, 88 can be fixed to the respectivecomponents by various joining mechanism including welding, soldering,adhesives, mechanical interference fit and the like. In FIG. 4A, whenthe biasing member 82 is a helical torsion spring, a moment can becreated about the axis of the coil 84 such that each of the shells 60,62 provides a radially inward retaining force Fs, opposing one another.The radially inward retaining force Fs can be applied along the recessalong a plane that is preferably extends generally through thelongitudinal axis LA of the prosthesis. The combined opposed radiallyinward retaining forces are greater than the radial expansion forces ofthe prosthesis such that the shells can retain the prosthesis in thecompressed configuration.

FIGS. 4A-4C illustrate the operation of deployment device 10 in removingthe shells 60, 62 of the retaining member 14 from prosthesis 15 forexpansion thereof. FIG. 4A depicts the retaining member 14 in the closedposition to retain the prosthesis 15 in the radially compressedconfiguration. The distal surface 28 of the distal portion 26 of theplunger 20 is at rest at the first position. At the first position, thedistal surface 28 of the plunger 20 may be spaced from, or slightlycontacting, the retaining engaging surface 77 formed by the innerengaging surfaces 74. The biasing member 82 can bias each of the shells60, 62 in the closed position with the opposing radially inwardretaining forces Fs.

An end user can place his or her palm and fingers around theintermediate body 34 in order to place the thumb on the plunger 20 foractuation of the plunger. Optionally, an end user can place his or herpalm of a single hand on the proximal surface 40 of the proximal portion22 of the plunger 20, and curl his or her one or more fingers of thesame hand around the proximal portion 32 of the support frame 18 toplace the fingers around the intermediate portion 30 of the supportframe. The portions of the support frame 18 and the plunger 20 areconfigured to be manipulated and handled by the end user, and preferablysized to fit within a single hand of the end user to allow for operationby a single hand. With the retaining member 14 in the closed positionand the plunger at the first position, the hand of the end user canapply a force F along the translational axis TA at the proximal surface40 of the proximal portion 22 of the plunger 20, which is transmitted tothe distal surface 28 of the distal portion of the plunger 20. Force Fcan be at least greater than the opposing radially inward retainingforce Fs of each shell provided by the biasing member.

In FIG. 4B, under the force F, the proximal surface 40 of the plunger 20is moved along the translational axis TA relative to the support frame18 away from the first position in a closer proximity to the proximalportion 32 of the support frame 18. Consequently, the distal surface 28of the distal portion 26 of the plunger 20 translates downward to anintermediate third position, between the first and second positions,slidably engaging the retaining engaging surface 77. The inner engagingsurfaces 74 of shells 60, 62 and the confronting surfaces 71 begin toseparate from one another as the shells 60, 62 begin to be pivotablydisplaced outward about the respective pivot axes. To this end, thesurfaces defining the recesses 70 begin to move outward away from oneanother to permit the prosthesis to begin expanding to the expandedconfiguration. It is contemplated that the distal surface 28 of theplunger and the inner engaging surfaces 74 of the shells can beconfigured for smooth slidable engagement, such as being coated with alubricious coating such as PTFE.

In FIG. 4C, under the force F, the proximal surface 40 of the plunger 20is moved along the translational axis TA relative to the support frame18 away from the first position in a closer proximity to the proximalportion 32 of the support frame 18. Consequently, the distal surface 28of the distal portion 26 of the plunger 20 translates downward away fromthe third position to the second position, slidably engaging the innerengaging surfaces 74 of shells 60, 62. The inner engaging surfaces 74 ofthe shells 60, 62 and the confronting surfaces 71 are separated fartherfrom one another as the shells 60, 62 are pivotably displaced outwardabout the respective pivot axes so that the retaining member 14 assumesthe open configuration. To this end, the surfaces defining the recesses70 are moved outward away from one another to permit the prosthesis tofully expand to the radially expanded configuration.

FIG. 5 depicts another embodiment of a deployment device 110 having thehandle portion 112 and the retaining member 114 that can retain theprosthesis 15 in the radially compressed configuration. The handleportion 112 can include the actuation member 116, such as the plunger120, slidably coupled to the support frame 118. In this embodiment, thedevice includes retractable ends that cover the outer ends of theprosthesis. For example, the retractable cuffs 200 are disposed at theaxial ends 169A, 169B of the distal portion 168 of the shells 160, 162.The retractable cuffs 200 can be configured to facilitate insertion ofthe ends of the prosthesis 15 into the body vessel portions.

For example, each of the shells 160, 162 include the proximal portion166 hingedly attached to the support frame 118 and the distal portion168. A biasing member (not shown) may bias the shells in the closedposition. A support member 173 may extend between the proximal anddistal portions 166, 168. The support member 173 can be located at anintermediate region of the proximal and distal portions, and preferablyat the center of each such that the distal portion extendslongitudinally beyond the support member. The longitudinal recess 170can be formed in the confronting surface 171 of the distal portion 168as shown in FIG. 7.

In FIG. 6, the retractable cuff 200 is movable from the end of theprosthesis in a direction toward the middle of the prosthesis, with theends of the prosthesis extending longitudinally beyond the ends of thedistal portion 168. To this end, the retractable cuff is movable betweena delivery configuration and a deployed configuration. The retractablecuff 200 can include a tubular body 204 having a first end opening 205and a second end opening 206. The first end 205 of the body 204 may alsobe a tapered end 208 extending over the end of the prosthesis tofacilitate insertion of the end of the prosthesis into the body vesselportion. In FIG. 5, in one example, a control member 210, such as a wireand/or rod, can be coupled to the retractable cuff 200, and an operableelement, such as a pull tab 214, can be coupled to the control member210. The pull tab 214 can be selectively operable to cause theretractable cuff 200 to move between the delivery and deployedconfigurations.

The body 204 of the retractable cuff 200 can extend longitudinallybeyond the end of the distal portion 168 to surround the outer end ofthe prosthesis. The body 204 can be configured to slidably engage theouter surface of the distal portion 168. In one example, the retractablecuff 200 is splittable into two portions 220A, 220B so that when theshells 160, 162 are pivoted outward about the respective pivot axes theretractable cuff portions remain coupled to the respective shell. Tofacilitate coupling and slidability of the retractable cuff portions tothe distal portions of the shells 160, 162, a track 230 can be includedon the outer surface of the distal portion 168. A channel 232 can alsobe included along the inner surface of the retractable cuff portions220A, 220B for slidably receiving the track 230. The track and thechannel can be sized and shaped to prevent the channel from being pulledaway from the track in an outward direction. To this end, the track andthe channel can have an increasingly smaller cross-section in order tofacilitate the mating relationship with one another. In thecross-sectional view of FIG. 7, the track 230 and the channel 232 can bet-shaped so that the head 234 of the track defines a repeatable andconsistent sliding longitudinal pathway and the stem 236 permits theretention of the retractable cuff portions 220A, 220B from being easilyremoved in the outward direction.

A first end of the control member 210 can be coupled to the retractablecuff portions 220A, 220B of each retractable cuff 200, for example, at amounting portion 240 that is coupled to the outer surface of the body204. The control member 210 can extend longitudinally along thelongitudinal axis LA external to the distal portion 168 into an entryport 242 formed in the shells 160, 162. The control member 210 can bethen redirected axially along the translational axis TA through a firstconduit (not shown) formed in the shells 160, 162 and can exit throughan exit port (not shown) formed in the inner engaging surface 174. Theentry port 242 can be a rounded or tapered surface or can include awheel to facilitate redirection and transmission of force of the controlmember. The control member 210 can continue along the translational axisTA through an entry port (not shown) of the support frame 118 andthrough a second conduit (not shown) formed in the support frame 118.The first and second conduits may be lubricated to facilitate movementof the control member. A second end of the control member 210 can extendbeyond an exit port 244 formed in the proximal portion 132 of thesupport frame 118 so that the pull tab 214 is positioned along thesurface 246 of the proximal portion 132, as shown in FIG. 8A. The pulltab 214 can be a ring structure having an aperture 248 formed thereinsized for a finger of the end user to fit within. The pull tab 214 canhave a planar surface 250 for contacting the planar surface 246 of theproximal portion 132.

In FIGS. 8A-8B, the pull tab 214 can be selectively operable to causethe retractable cuff 200 via the control member 210 to move between thedelivery configuration (shown in phantom lines) and the deployedconfiguration to allow for expansion of the respective end of theprosthesis. Thus, the pull tab 214 is movable between a first positionwhere the retractable cuff 200 is in the delivery configuration, asshown in FIG. 5, and a second position where the retractable cuff 200 isin the deployed configuration, as shown in FIGS. 8A-8B. The pull tab 214(two pull tabs shown) can be coupled to the retractable portion 220A viaa first control member and to the retractable portion 220B via a secondcontrol member (shown as control member 210). Hence, a single pull tab214 can be moved to the second position to remove simultaneously theretractable cuff portions 220A, 220B of a single retractable cuff 200from one end of the prosthesis. The other pull tab can also be similarlymoved to retract the other cuff. This arrangement can permit sequentialdeployment of the ends of the prosthesis into the body vessel portions.It is contemplated that a pull tab can be coupled to a singleretractable cuff portion 220A or 220B such there are a total of fourpull tabs, and two pull tabs can be pulled to remove the retractablecuff 200 from the end of the prosthesis. It is further contemplated thata single pull tab can be coupled to each retractable cuff such that asingle pull tab 214 can be pulled to remove the retractable cuffs 200from both ends of the prosthesis simultaneously. In one example, abiasing member such as a spring can be provided to bias the retractablecuffs in either the delivery or deployed configurations. Further, theretractable cuff portions 220A, 220B may be configured to lock in thedeployed configuration after being moved there.

Operation of the deployment device will now be discussed. Although thediscussion will focus primarily on the operation of deployment device10, it can be appreciated by those skilled in the art that the otherembodiments of the deployments devices described herein can be similarlyoperated and used.

FIGS. 9A-9F illustrate a method of treating a body vessel 320, found forexample in the leg of a patient, which has previously been subjected toa traumatic episode, resulting in a portion 322 of body vessel 320 beingtorn away or otherwise severely damaged. Pre-surgery preparation hasbeen applied to the leg and a trauma pathway may be formed therein inorder to gain access to the body vessel and the damaged portion thereof.After clamping body vessel 320 on both ends of the portion 322 torestrict blood flow temporarily, the body vessel 320 can be cut ortransected by the clinician into two portions 320A, 320B. Thetransection may be at the damaged portion 322 of the blood vessel 320 oras far away as necessary from the damaged portion to remove unhealthyportions of the body vessel or unrepairable portions of the body vessel.Sutures 324 can be attached to the end openings 325 of body vesselportions 320A, 320B to keep them fixed in place and opened to facilitateinsertion of the prosthesis. Forceps may also be used in a similarmanner. Any number of sutures can be used to retain the end openings 325in the open position, although triangulation sutures can be sufficient,with each suture being about 120 degrees apart from the adjacent suture.A prosthesis is selected to have a radial expanded cross-section and alongitudinal length sufficient to bridge the body vessel portions 320A,320B and radially fit within the body vessel portions.

According to FIG. 9C, the prosthesis 15, which is preloaded within thedeployment device 10, is shown being situated and oriented adjacent thebody vessel portion 320A through the trauma pathway. The prosthesis 15,which is in the delivery, compressed configuration, is retained in theradially compressed configuration by the retaining member 14. The firstouter end 330A of the prosthesis 15 can be inserted into vessel portion320A by a sufficient distance for the purposes of engagement and/oranchoring. It is preferred that the vessel portion initially selected bethe non-blood supplying vessel end. The vessel portion 320A may bemanually pulled over the first outer end 330A of the prosthesis 15. Thedeployment device 10 and the prosthesis 15 can then be manipulated inorder to introduce a second outer end 330B of the prosthesis 15 into thevessel portion 320B by a sufficient distance for the purposes ofengagement and/or anchoring.

In FIG. 9D, after insertion of both outer ends 330A, 330B of theprosthesis 15 into the end opening 325 of the respective portions 320A,320B of the body vessel 320, the actuation member can be operated topivot the desired shells 60, 62 of the retaining member 14 away fromprosthesis 15. This can permit expansion and engagement of a portion ofprosthesis 15 along the wall of the vessel portions 320A, 320B. Thevessel portions 320A, 320B can now be sealably engaged to first andsecond outer ends 330A, 330B of the prosthesis 15. Accordingly, theprosthesis 15 is fully deployed to bridge the first and second portions320A, 320B of the transected body vessel 320 to form a conduit for bloodflow. The sutures 324 can then be removed. Preferably, portions of theexterior surfaces of the prosthesis sealably engage with the luminalwalls of the body vessel to inhibit leakage of blood and to force bloodto flow throughout the body vessel during emergency surgery, andparticularly to obtain hemostasis while maintaining blood perfusion.FIG. 9E shows the prosthesis 15 deployed and interconnecting the bodyvessel portions 320A, 320B within the leg of the patient. The prosthesis15 can be adapted for permanent placement within the patient, therebyobviating a need for subsequent surgical intervention.

FIGS. 10A-10C illustrate operation of the device 110 that includes theretractable cuffs 200. According to FIG. 10A, the prosthesis 15, whichis preloaded within deployment device 110, is shown being situated andoriented adjacent the body vessel portions 320A, 320B through the traumapathway. The prosthesis 15, which is in the delivery, compressedconfiguration, is retained in the radially compressed configuration bythe retaining member 114. The first and second outer ends 330A, 330B ofprosthesis 15 are retained in the compressed configuration by theretractable cuff 200 that is in the delivery configuration. The cuffs200 which cover the outer ends of the prosthesis can be inserted intothe respective vessel portions 320A, 320B by a sufficient distance forthe purposes of engagement and/or anchoring.

In FIG. 10B, the pull tabs 214 can be withdrawn to the second position,in the direction of arrows 340, sequentially or simultaneously asdescribed herein, to cause the retractable cuff 200 to move to thedeployed configuration to allow for expansion of the respective firstand second outer ends 330A, 330B of prosthesis 15. Here, the outer endsof the prosthesis may be in engagement along the wall of the vesselportions 320A, 320B. Optionally, the outer ends of the prosthesis mayexpand less than the cross-sectional area of the body vessel. Thisremoves the cuffs from the body vessel so that when the retaining memberis moved to the open position the cuffs have sufficient clearance withrespect to the body vessel portions. With the retraction cuffs in thedeployed configuration, the actuation member 116 can be moved relativeto the support frame in the direction of the arrow 350. As a result, theshells 160, 162 of the retaining member 114 can move away from theprosthesis 15, as shown in FIG. 10C. This can permit full expansion andengagement of a portion of the prosthesis 15 along the wall of thevessel portions 320A, 320B.

FIGS. 11-14 depict another embodiment of a deployment device 410 havingthe handle portion 412 and the retaining member 414 that can retain theprosthesis 15 in the radially compressed configuration. The handleportion 412 can include the actuation member 416 slidably coupled to thesupport frame 418. In this embodiment, the retractable cuffs 419 aredisposed at the axial ends 469A, 469B of the distal portion 468 of theshells 460, 462.

The actuation member 416 can include a first or proximal portion 422, anintermediate shaft 424, and a second or distal portion 426 coupled toone another. The support frame 418 can include a tubular body 430 thatcan have a proximal portion coupled to the handle portion 412, anintermediate portion 434, and a distal portion 436 coupled to oneanother. The tubular body 430 can define a passageway (not shown) aboutthe translational axis TA that can extend through the tubular body. Thepassageway is sized to receive the intermediate shaft 424 so that theactuation member is capable of being translated along the translationalaxis between a first position and a second position. The device 410 mayinclude a biasing member such as a spring that is configured to bias theretaining member in the closed position when the actuation member is inthe first position. The biasing member can also be coupled to theactuation member, such as within the body 430, to bias the actuationmember in the first position, as can be appreciated by those skilled inthe art. The proximal portion 422 can have an operable element, such as,e.g., a longitudinal dial 435 that is movable, such as e.g., downward,within a slot formed in the support frame 418 to cause the shells topivot to the open position. The dial 435 may extend outwardly from afront face of the handle portion.

FIG. 12 depicts the distal portion 426 that can extend distally beyond arecessed notch 437 formed in the distal portion 436 of the supportframe. The distal portion 426 can be a downward C-shaped body having apair of legs 440 extending downwardly for coupling to the shells 460,462. The distal portion 436 with the notch 437 formed therein from theend of the support frame in a proximal direction can define a pair offinger members 439. The notch 437 is sized to receive the proximalportion 466 of the shells. Further, the proximal portion 466 of theshells can be placed adjacent to one another and together sized to fitbetween the legs 440 of the distal portion 426.

The shells 460, 462 together are configured to define the prosthesisretaining chamber 464 about the longitudinal axis LA of the prosthesiswhen the retaining member is in the closed position. Each of the shellscan include the proximal portion 466 and the distal portion 468. Thelongitudinal recess 470 can be formed in the confronting surface 471 ofthe shell along the distal portion, such as shown in FIG. 13. Theproximal portion 466 of the shells can be coupled to the distal portion436 of the support frame 418 and the distal portion 426 of the actuationmember 416. In one example, a pivot rod 441 may be extended laterallyacross the notch 437 to be fixed in a secured position with the fingermembers 439. The proximal portion 466 of the shells can have a boreextending laterally through the body of the shells for receiving thepivot rod 441. To this end, the shells 460, 462 can pivot about thepivot rod 441 between the closed position (FIG. 13) and the openposition (FIG. 14) for delivery and deployment of the prosthesis.

Further, the proximal portion 466 of the shells can have an elongateslot 443 extending laterally through the body of the shells, as shown inFIG. 14. The first end 444A of the slot 443 can be formed in a centralpart of the shell and the second end 444B of the slot 443 may terminatecloser to the edge of the shell than the first end. A control pin 445can be extended laterally in order to be fixed in a secured positionwith the legs members 440 and to be received by the slots 443. When theactuation member 416 is in the first position, the control pin 445 ispositioned at the first end of the slots 443 that overlap one anotherwhen the shells are in the closed position shown in FIG. 13. Withmovement of the actuation member 416 toward the second position, such asdownward movement, the control pin 445 slidably engages the edges 447that define the slot 443 toward the second end 444B of the slots,thereby causing the shells to pivot farther away from each other towardthe open position as shown in FIG. 14. The control pin 445 can betranslated along the translational axis and be moved relative to thepivot rod 441 that is in a fixed position. When the actuation member 416is, in the second position, the control pin 445 is positioned at thesecond end 444B of the slots 443 to cause the first end 444A of theslots to pivot away from each other and the shells to move to the openposition, as shown in FIG. 14.

Referring back to FIG. 11, the retractable cuffs 419 can extendlaterally beyond the sides 469A-B of the distal portion 468 to surroundthe outer ends of the prosthesis. To facilitate coupling and slidabilityof the retractable cuffs relative to the distal portions of the shells460, 462, one or more tracks 463, e.g., three tracks are shown at about60 degrees apart, can be included on the outer surface of the distalportion 468, as shown in FIG. 13. One or more channels 465 can also beformed along the inner surface of the retractable cuffs for slidablyreceiving the corresponding track 463. The track 463 and the channel 465can be sized and shaped to prevent the channel from being pulled awayfrom the track in an outward direction. To this end, the track and thechannel can have an increasingly smaller cross-section to mate withanother. In one example, the track can be circular with an increasinglysmaller cross-section toward the surface of the cuff, and the channelcan be circular shaped with an increasingly smaller cross-section towardthe surface of the shell, as shown in FIGS. 13-14. The retractable cuff419 can include a radial flange sized greater than the vessel. Theradial flange can function as a physical stop to control the insertiondistance of the cuff within the vessel portions. The cuff may also havea tapered outer surface to facilitate insertion into the vessel portion.

In FIG. 12, the control member 475 can be coupled between theretractable cuff 419 and one or more operable elements, such as alongitudinal dial 477, which is shown as two dials in FIG. 11. The dial477 can be movable within a slot formed in the handle portion 412. Thedial 477 may extend outwardly from a front face of the handle portion,and can be located underneath the dial 435. The dial 477 can beselectively operable to move the retractable cuff 419 between thedelivery and deployed configurations. A first end of the control member475 can be coupled to the retractable cuffs 419. The control member 475can extend from the first end longitudinally along the longitudinal axisLA into a port 478 that formed in an ear portion 479 that extendsoutward from the shells 460, 462. The port 478 may be tapered tofacilitate movement of the control member between the longitudinal andtranslational axes. The control member 475 can extend through a conduitformed in the support frame 418 so that a second end of the controlmember 475 is coupled to the dial 477. In one example, the controlmember 475 can include a flexible wire, such as stainless steel or otherknown metal suitable for medical procedures. In another example, thecontrol member is a hybrid member, being formed of a wire from the firstend of the control member to at least the ear portion, and being formedof a rigid shaft, such as a stainless steel shaft or other biocompatiblemetal or plastic shaft, to facilitate transmission of forces from thedial.

The dial 477 can be selectively operable, such as upward, to cause theretractable cuff 419 via the control member 475 to move between thedelivery and deployed configurations to allow for expansion of therespective end of the prosthesis such as shown in FIGS. 10B-10C. Thedial 477 is movable within the slot between a first position where theretractable cuff 419 is in the delivery configuration, and a secondposition where the retractable cuff 419 is in the deployedconfiguration. Each of the dials 477 can be coupled to one of theretractable cuffs 419 for sequential operation, although one dial may becoupled to both of the two retractable cuffs for simultaneous operation.Operation of the device 410 with movement of the shells and the cuffs todeploy a prosthesis to treat a body vessel can be gained with additionalreference to FIGS. 9A-9E and FIGS. 10A-10C, as can be appreciated by oneskilled in the art.

FIGS. 15A-15B depict another embodiment of a deployment device 510having the handle portion 512 and the retaining member 514 that canretain the prosthesis in the radially compressed configuration. Thehandle portion 512 can include the actuation member 516 slidably coupledto the support frame 518. In this embodiment, the actuation member 516and other movable components can be fully enclosed within the housing ofthe support frame 518 and the retaining member 514. This arrangement canprotect the body and various body tissues from inadvertent harmfulcontact from the movable components of the device, as well as providingthe movable components freedom to move without being obstructed fromportions of the body. FIGS. 15A-15B illustrate the movement of some ofthe components. For example, FIG. 15A shows the actuation member 516 inthe first position, the retaining member 514 in the closed position, andthe retractable cuffs 519 in the delivery configuration. FIG. 15B showsthe actuation member 516 in the second position, the retaining member514 in the open position, and the retractable cuffs 519 in the deployedconfiguration.

FIG. 16 illustrates the device 510 with one-half (i.e., the bottom half)of the housing of the support frame 518 and the second shell 562 removedin order to gain an appreciation of the movable components within thehousing. The actuation member 516 can include a first or proximalportion 522, an intermediate shaft 524, and a second or distal portion526 coupled to one another. The support frame 518 can be a hollowhousing having a first portion 530 and a second portion 531 (shownremoved in FIG. 16) that together define a cavity. The proximal portion522 of the actuation member can have an operable element coupledthereto, such as, e.g., a longitudinal dial 535, that is movable, suchas e.g., downward, within a slot 536 formed in the first portion 530 inorder to move the retaining member 516 to the open position. The dial535 may extend outwardly from a front face of the handle portion. Theintermediate shaft 524 can have a longitudinal slot 538 formed therein.The slot 538 can fit over a longitudinal protrusion (not shown) formedon the inner surface of the second portion 531 of the support frame 518to form a guide or track system for facilitating movement and stabilityof the actuation member relative to the support frame. The device 510may include a biasing member (not shown) such as a spring to bias theactuation member in the first or second position and thus the retainingmember in the closed position or open position, as can be appreciated bythose skilled in the art.

FIG. 15B depicts the second shell 562 integral with the second portion531 of the support frame, whereas the first shell 560 is hingedlyattached to the first portion 530 of the support frame. FIG. 16 shows apair of opposite sidewalls of the first shell 560 hingedly attached to apair of opposite sidewalls of the first portion 530 at the pivotattachment 563. The pivot attachment 563 between the first shell 560 andthe first portion 530 can be formed with various hinge mechanisms knownin the art such as a rivet, nut/bolt, or other mechanical fasteners,which are inserted through openings formed in the respective components.The first shell 560 is also hingedly attached to the distal portion 526of the actuation member. For example, the distal portion 526 can have arecessed notch 537 formed in the end of the shaft 524 in a proximaldirection to define a pair of finger members. The notch 537 is sized toreceive an ear member 539 that extends outwardly from the inner surfaceof the first shell 560. A coupling pin 541 can be extended throughopenings formed in the finger members and in the ear member 539 to formthe hinge attachment 542. The opening in the ear portion 539 can be anelongate opening, such as shown in FIG. 16. The coupling pin 541 canrest at one end of the elongate opening when the actuation member 516 isat the first position. The coupling pin 541 can be moved within theopening toward the opposite end of the elongate opening when theactuation member is moved toward the second position. The plane, alongwhich the coupling pin 541 is moved along, can remain offset from thepivot axis PA defined by the pivot attachments 563 to create a momentand rotation of the first shell 560 about the axis PA. To this end,linear movement of the actuation member 516 toward the second positionurges the first shell 560 to pivot about the pivot axis PA of the pivotattachment 563 away from the second shell 562. This movement moves theretaining member 514 to the open position, such as shown in FIG. 15B, sothat the intermediate segment of the prosthesis is permitted to move theexpanded configuration.

The shells 560, 562 together are configured to define the prosthesisretaining chamber 564 about the longitudinal axis LA of the prosthesiswhen the retaining member 514 is in the closed position, as shown inFIG. 15A. A longitudinal recess may be formed in the confrontingsurfaces of the shells to form the retaining chamber. In anotherexample, an insert 565 can be located within each of the shells 560, 562to reinforce the retention of an intermediate segment of a prosthesis. Apair of inserts 565 together define a tubular chamber, as shown in FIG.16, that is sized to receive at least a portion of the prosthesis. Theinserts 565 can be made of a rigid material such as metal or polymer.Each insert 565 can be attached to a corresponding shell, and theinserts 565 are splittable upon movement of the shells 560, 562 to theopen position.

FIGS. 15A and 16 illustrate the retractable cuffs 519 extended outwardfrom the lateral sides 569A, 569B of the distal portion 568 of theshells 560, 562 through an opening formed by the shells. FIGS. 17A-17Dshow various aspects of the retractable cuffs. Here, the retractablecuff has a first cuff portion 572 (FIGS. 17A-17B) and a second cuffportion 574 (FIG. 17C) that couple to one another as shown in FIG. 17D.In FIGS. 17A-17B, the first cuff portion 572 can include a chamberportion 576 and a plate 578 attached to one end of the chamber portion576 and extending generally perpendicular thereto. The first cuffportion 572 is typically associated with the second shell 562. Anopening in the plate 578 and the opening defined by the chamber portion576 together define a first recess 579. The plate 578 can include a nub580 on one lateral side of the plate, which extends along the samedirection as the chamber portion. A through bore 582 and an open recess584 can be formed in the plate 578, e.g., along the proximal portion ofthe plate, generally along the same direction as the chamber portion. Anotch 586 can be formed in the plate, generally perpendicular to thechamber portion, and is sized to receive the second cuff portion 574.

In FIG. 17C, the second cuff portion 574 can include a chamber portion588 and a plate 589 attached to one end of the chamber portion 588 andextending generally perpendicular thereto. The second cuff portion 574is typically associated with the first shell 560. A through bore 590 canbe formed in the plate 589, e.g., along the proximal portion of theplate, generally along the same direction as the chamber portion. Anopening in the plate 589 and the opening defined by the chamber portion588 together define a second recess 591.

FIG. 17D shows the first cuff portion 572 coupled to the second cuffportion 574 such that the first and second recesses 579, 591 form atubular segment of the prosthesis retaining chamber 564. The open recess584 of the first cuff portion 572 is in communication with the throughbore 590 of the second cuff portion 574. The tubular segment defined bythe first and second recesses 579, 591 can be sized larger than the sizeof the tubular chamber defined by the inserts 565, if employed. Suchtubular segment of the first and second portions 572, 574 can fit overand slide along the tubular chamber defined by the combined inserts 565.To reinforce the radial strength of the cuff, a retention member 592 canfit over the respective chamber portions 576, 588 of the cuff. Theretention member 592 can have a C-shape and is sized circumferentiallyat least to cover the seams formed by the coupled chamber portions ofthe cuffs. The retention member 592 can be attached or otherwise remainassociated with the first cuff portion 572, such as being formedintegrally with the first portion. The first and second cuff portions572, 574 are capable of being split apart upon relative movement betweenthe first and second shells 560, 562. To this end, the retention member592, which is fitted over the chamber portion 576 of the first cuffportion 572, can have a slot 593 that is sized to permit the passage ofthe chamber portion 588 of the second cuff portion 574 therethrough.

In FIG. 17D, a pair of rods 594, 596 (shown in dashed lines) can beextended laterally between the sidewalls of the respective first andsecond shells and coupled thereto to provide guides for the retractablecuffs 519. For example, a first rod 594 can be coupled to the firstshell 560, as shown in FIG. 19A. The second cuff portion 574 may beretained within the first shell by the first rod 594. The first rod 594can be received within the through bore 590 of the second cuff portion574 and the open recess 584 of the first cuff portion 572 of each of thecuffs. A second rod 596 can be coupled to the second shell 560. Thefirst cuff portion 572 may be retained within the second shell by thesecond rod. The second rod 596 can be received within the through bore582 of the first cuff portions 572 of each of the cuffs. The cuffs 519can be moved longitudinally inward along the rods 594, 596, which aretypically in a parallel orientation with one another, between thedelivery and deployed configurations. The open recess 584 of the firstcuff portions that are associated with the second shell 562 can allowthe first rod 594 that is associated with the first shell 560 to passtherethrough during movement of the shells to the open position. Aradial protrusion 595 can be formed on the inserts 565 to facilitateattachment to the support member. For example, an internal rib 597 witha recess formed therein can be provided along the inner surfaces of theshells to receive the inserts and the radial protrusion. The rib canalso provide a physical stop for the cuffs when moving inward.

In FIGS. 18-19, a release member can be associated with each of thecuffs to provide selective movement of the cuffs. The release members605 can be disposed within the support frame 518. A proximal portion 606of the release member can have an operable element coupled thereto, suchas, e.g., a longitudinal dial 608 shown in FIG. 15A, that is movable,such as e.g., upward, within a slot 609 formed in the first portion 530in order to move the release members from the first position to thesecond position. The dial 608 may extend outwardly from a front face ofthe handle portion. The dial 608 can be selectively operable to move theretractable cuff 519 between the delivery and deployed configurations.The dial 608 is movable within the slot 609 between a first positionwhere the retractable cuff 519 is in the delivery configuration, and asecond position where the retractable cuff 519 is in the deployedconfiguration. Each of the dials 608 can be operable for independentsequential retraction of the cuffs or for simultaneous retraction of thecuffs. An intermediate shaft 612 of the release member can have alongitudinal slot 614 formed therein. The slot 614 can fit over alongitudinal protrusion (not shown) formed on the inner surface of thesecond portion 531 of the support frame 518 to form a guide or tracksystem for facilitating movement and stability of the release membersrelative to the support frame.

When in the first position, the distal end 616 of the release member 605is sized to fit within a space between the internal rib 597 and theplate of the cuffs 519 to maintain the cuffs in the delivery positionover the outer end of the prosthesis 15, as shown in FIG. 18A. In thisposition, the cuff 519 makes up a portion of the prosthesis retainingchamber 564. Upon removal of the distal end 616 from such space, thecuff 519 is capable of moving inward to the deployed configuration, asshown in FIG. 19A. A biasing member 620 such as a spring can be coupledbetween the retractable cuff 519 and the support frame 518. The biasingmember 620 can be configured to bias the cuff in either the delivery ordeployed configurations. For example, the biasing member 620 can biasthe cuff in the deployed configuration such that upon removal of therelease member 605 the cuff 519 can automatically move from the deliveryconfiguration to the deployed configuration, such as shown in FIGS.19-19A. The biasing member 620 can be oriented along the longitudinalaxis LA to maximize the spring force of the biasing member to overcomethe frictional and engagement forces between the cuff and theprosthesis. This arrangement permits the outer end of the prosthesis tobe expanded, while the intermediate segment of the prosthesis isretained by the retaining member. One end of the biasing member 620 canfit over the nub 580 of the cuff 519 and the opposite end can bereceived in the cavity of an end cap 622 formed in the sidewall of thesupport member. The end cap 622 can be sized to receive the nub 580 whenthe biasing member 620 is fully axially compressed when the releasemember is at the first position, such as shown in FIG. 18A. Operation ofthe device 510 with movement of the shells and the cuffs to deploy aprosthesis to treat a body vessel can be gained with additionalreference to FIGS. 9A-9E and FIGS. 10A-10C, as can be appreciated by oneskilled in the art.

FIG. 20 illustrates another embodiment of a deployment device 700 havinga retractable cuff that can be directly moved by the end user. Theretractable cuff 710 has similar aspects to the retractable cuff 519shown in FIGS. 17A-17C. The retractable cuff 710 includes a first cuffportion 712 associated with the first shell (not shown) and a secondcuff portion 714 associated with the second shell 715. The first cuffportion 712 can include a chamber portion 720 and a plate 722 attachedto one end of the chamber portion 720 and extending generallyperpendicular thereto. An opening in the plate and the opening definedby the chamber portion together define a first recess. A through bore725 (two shown) can be formed in the plate. The second cuff portion 714can include a chamber portion 730 and a plate (not shown) attached toone end of the chamber portion 730 and extending generally perpendicularthereto. An opening in the plate and the opening defined by the chamberportion together define a second recess.

The first cuff portion 712 can be coupled to the second cuff portion 714such that the first and second recesses together form a tubular segment735 of the prosthesis retaining chamber. A pair of rods 736 can beextended laterally between the sidewalls of the first shell and coupledthereto to provide guides for the retractable cuffs. For example, thefirst cuff portion 712 can be retained within the first shell by therods 736. The rods 736 are received within the through bores 725 of thefirst cuff portion 712. The cuffs 710 can move along the rods 736between the delivery configuration shown in FIG. 20 and the deployedconfiguration where the cuffs 710 are removed from the outer segments ofthe prosthesis. When the shells are separated from one another to theopen position, the first and second cuff portions 712, 714 can beseparated from one another to allow for expansion of the intermediatesegment of the prosthesis.

An operable element 740 can be coupled to each of the retractable cuffs710. The operable element 740 can extend out from an aperture 742 formedin the support frame 745. The operable element 740 can have a notch 746formed therein. The notch 746 is sized to receive a track 748 providedwith the support frame that provides a guide surface for the operableelement 740 when moving toward the middle of the support frame 745. Asupport aim 750 can couple the operable element 740 directly to thefirst and second cuff portions 712, 714. To operate the retractable cuff710, a force is applied to the operable element 740 in the inwarddirection, represented by arrow 755 along the direction of thelongitudinal axis LA when the shells are in the closed position. Theoperable element 740 can be guided along the track 748 and the first andsecond cuff portions 712, 714 can move with the operable element 740along the rods 736 in a corresponding manner. Each operable element 740can be moved independent from one another for simultaneous or sequentialmovement of the cuffs. Operation of the device with movement of theshells and the cuffs 710 to deploy a prosthesis to treat a body vesselcan be gained with additional reference to the figures, such as FIGS.9A-9E and FIGS. 10A-10C, as can be appreciated by one skilled in theart. It can be appreciated that the device 700 includes a retainingmember, which can be moved by the various mechanisms described herein,in order to allow for expansion of the prosthesis.

FIGS. 21-25 illustrate another embodiment of a deployment device 800having many of the features described in the previous embodiments. Forexample, the device 800 has the handle portion 812, the retaining member814 that can retain the prosthesis in the radially compressedconfiguration, and the actuation member 816 with the dial 817 at theproximal end thereof. The actuation member 816 is movable between firstand second positions to move the retaining member between the closedposition (FIG. 21) and the open position (FIG. 22), respectively. FIG.22 illustrates the entire retaining member 814 is axially movable alongthe translational axis TA when moving between the open and closedpositions.

FIG. 23A-23B illustrate example construction of the actuation member 816and the release members 819. The actuation member 816 includes a distalend 820 having a U-shape. A pin 824 can be included between the two legsof the distal end 820. The pin 824 is shown to carry several componentsand can provide a common pivot axis for such components. For example,the shells or clamps 830, 831 and the first and second cuff portions832, 834 of the retractable cuffs 835 are capable of rotating about thepin 824. The biasing member 838, shown as a spring, is disposed tosurround the pin 824, extending between the inner surface of the legs ofthe distal end 820 and the first cuff portion 832 in order to bias thecuffs in the retracted position or deployed configuration. To maintainthe cuffs 835 in the delivery configuration, the distal end 840 of therelease member 819 is positionable in between the second cuff portion834 and the proximal portion 842 of the shells 830, 831. For example,the distal end 840 of the release member can be a C-shaped tubularmember to fit around the pin 824. The first of the release members 819is shown in the delivery position to maintain the first of the cuffs 835in the delivery configuration. The second of the release members 819 isshown in the deployed position to allow the second of the cuffs 835 tomove to the deployed configuration, which movement can be facilitated bythe biasing member 838.

FIG. 24 illustrates the distal end of the shell, represented by theshell 831. When the shells 830, 831 are in the closed position, theshells 830, 831 together define an inner tubular member having a chamberextending therethrough for retaining the prosthesis and an outer tubularmember positioned in a spaced relationship relative to the inner tubularmember to define a curved tracking channel for receiving the cuffs 835.To this end, the shell 831 includes an inner semi-circular portion 845that defines a portion of the inner tubular member and an outersemi-circular portion 847 that defines a portion of the outer tubularmember. As shown, the cuff portion, represented by the first cuffportion 832, is shaped and sized to fit within the tracking channel 849,over the inner semi-circular portion 845 and within the outersemi-circular portion 847.

FIG. 25 illustrates another aspect of the distal end of the shell 831.The proximal portion 842 of the shell 831 is angled in a manner to placethe opening 850 that receives the pin 824 at the apex 852 of theproximal portion 842. The proximal end 854 is engaged with a guidingsurface 855 that protrudes from the inner wall 856 of the housing (i.e.,the bottom half) of the support frame to define a cam configuration. Theguiding surface 855 is shaped to change in elevation, e.g., the guidingsurface 855 is curved outward away from the inner wall 856. The curve ofthe guiding surface 854 can be uniform or can become gradually steeperin the distal direction as shown in FIG. 22. During linear movement ofthe actuation member 816 along the translational axis TA from the firstposition to the second position, the proximal end 854 slidably engagesthe guiding surface 855 to follow the curvature of the guiding surface855. As a result, the shells 830, 831 are rotated about the pin 824 awayfrom one another in order to allow the prosthesis to move to theexpanded configuration. Operation of the device 800 with movement of theshells and the cuffs to deploy a prosthesis to treat a body vessel canbe gained with additional reference to FIGS. 9A-9E and FIGS. 10A-10C, ascan be appreciated by one skilled in the art.

It can be appreciated by those skilled in the art that specific featuresof each embodiment of the deployment device are interchangeable amongthe device embodiments, even where no references to the specificfeatures are made. For example, the device can include a feature of thepreviously described devices 10, 110, 410, 700 and/or 800. Further, amodification described with respect to a single device may be includedwith the other devices 10, 110, 410, 700 and/or 800 described herein.

The components of the devices described herein can be machined or moldedfrom a biocompatible polymer or metal as can be appreciated by thoseskilled in the art. The actuation member can further comprise a driver,such as an electric motor coupled to a power source and/or controls forelectronically controlling the speed, direction, and force of theactuation member. In one example, the actuation member is operable witha push of a button as can be appreciated by ones skilled in the art.

A concise description of prosthesis 15 will now be provided. One exampleof such prosthesis 15 is described in U.S. patent application Ser. No.13/197,511, filed on Aug. 3, 2011, entitled “BLOOD PERFUSION DEVICE,”which is incorporated herein by reference in its entirety. Theprosthesis can include a generally tubular graft body and/or one or moreanchoring members and/or supporting members together defining a fluidpassageway. The prosthesis is movable between the radially compressed,delivery configuration and the radially expanded, deployedconfiguration. The prosthesis can be balloon expandable; however, it ispreferred that the prosthesis is self-expandable. The anchoring membersand/or supporting members can be attached to the graft body by suturessewn therein, wire, staples, clips, bonding agents, or other methodsthat may be used to achieve a secure attachment to the graft body. Theprosthesis has a size and shape suitable for at least partial placementwithin a body vessel, such as an artery or vein, and most particularly,for placement at the site of a vascular trauma. The prosthesis may beeasily manipulated during delivery to a transected artery or vein duringemergency surgery, and particularly, to obtain hemostasis whilemaintaining blood perfusion. The anchoring member and/or supportingmember can be any stent pattern known to one skilled in the art.Examples of stent patterns is the Z-STENT® and ZILVER® stent, eachavailable from Cook Medical Inc. (Bloomington, Ind.). The anchoringmember and/or supporting member can be formed of a biocompatible metal,such as stainless steel (e.g., 316L SS), titanium, tantalum, nitinol orother shape memory materials, or a high-strength polymer. Preferably,anchoring devices can be included on at least the anchoring members toprovide vessel fixation, while avoiding adverse conditions associatedwith disturbing the vasa vasorum and/or pressure induced necrosis of themedium muscular arteries of the type that may result from tyingligatures circumferentially around a connector or a vascular conduit.The anchoring devices can include various shaped member structures,including barbs, fibers, bristles, or outer protruding and penetrablemedia.

The graft body can be formed from conventional materials well known inthe medical arts. The graft body may comprise an expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene, silicone,polyurethane, polyamide (nylon), as well as other flexible biocompatiblematerials. The graft body can also be formed from known fabric graftmaterials such as woven polyester (e.g. DACRON®), polyetherurethanessuch as THORALON® from Thoratec Corporation (Pleasanton, Calif.),polyethylene such as an ultra-high molecular weight polyethylene(UHMwPE), commercially available as DYNEEMA®. The graft body may alsoinclude a bioremodelable material, such as reconstituted ornaturally-derived collagenous materials, extracellular matrix material(ECM), submucosa, renal capsule membrane, dermal collagen, dura mater,pericardium, fascia lata, serosa, peritoneum or basement membranelayers, intestinal submucosa, including small intestinal submucosa(SIS), stomach submucosa, urinary bladder submucosa, and uterinesubmucosa. One non-limiting example of a suitable remodelable materialis the SURGISIS® BIODESIGN™, commercially available from Cook MedicalInc. (Bloomington, Ind.). Another suitable remodelable material is thegraft prosthesis material described in U.S. Pat. No. 6,206,931 to Cooket al., which is incorporated herein by reference in its entirety.

Portions of the prosthesis can also include a coating of one or moretherapeutic agents along a portion of the stent structure and/or thegraft body. Therapeutic agents for use as biocompatible coatings arewell known in the art. Non-limiting examples of suitable bio-activeagents that may be applied to the vascular conduit includethrombo-resistant agents, antibiotic agents, anti-tumor agents,antiviral agents, anti-angiogenic agents, angiogenic agents,anti-mitotic agents, anti-inflammatory agents, angiostatin agents,endostatin agents, cell cycle regulating agents, genetic agents,including hormones such as estrogen, their homologs, derivatives,fragments, pharmaceutical salts and combinations thereof. Those skilledin the art will appreciate that other bioactive agents may be appliedfor a particular use. The bioactive agent can be incorporated into, orotherwise applied to, portions of the vascular conduit by any suitablemethod that permits adequate retention of the agent material and theeffectiveness thereof for its intended purpose. Although the device hasbeen described in connection with its primary intended use for repair ofvascular trauma, those skilled in the art will appreciate that thedevice may also be used to repair other traumatic conditions.Non-limiting examples of such conditions include aneurysms, such asabdominal aorta aneurysms, and surgery for tumor removal.

The axial length of the prosthesis 15 relative to the length of theprosthesis retaining chamber is such that ends of the prosthesis extendoutwardly beyond the chamber. In this instance, the ends of theprosthesis may be expanded to a greater diameter than the radiallycompressed diameter of the prosthesis retained within the chamber.Preferably, such greater diameter of the ends of the prosthesis is lessthan the overall diameter of the vessel portion end opening. In oneexample, the prosthesis may be specially configured so that radialcompression of a substantial intermediate portion of the prosthesis(e.g., at least about 80% L) to the first diameter, results in ends ofthe prosthesis (e.g., each up to about 10% L) having the greaterdiameter that is about 30% greater than the compressed configuration. Tothis end, the prosthesis is structured to expand up to about 3% indiameter or less for every 1% of exposed length.

Drawings in the figures illustrating various embodiments are notnecessarily to scale. Some drawings may have certain details magnifiedfor emphasis, and any different numbers or proportions of parts shouldnot be read as limiting, unless designated as such in the presentdisclosure. Those of skill in the art will appreciate that embodimentsnot expressly illustrated herein may be practiced within the scope ofthe present invention, including those features described herein fordifferent embodiments may be combined with each other and/or withcurrently-known or future-developed technologies while remaining withinthe scope of the claims presented here. It is therefore intended thatthe foregoing detailed description be regarded as illustrative ratherthan limiting. It should be understood that the following claims,including all equivalents, are intended to define the spirit and scopeof this invention.

We claim:
 1. A deployment system for deploying a prosthesis, comprising:a prosthesis expandable from a compressed configuration to an expandedconfiguration; a support frame, a first operable member coupled to thesupport frame, and a second operable member coupled to the supportframe, the first and second operable members each being movable relativeto the support frame between a first position and a second position; afirst shell and a second shell coupled to the first operable member andmovable between a closed position and an open position, wherein, in theclosed position, the first shell and the second shell are positioned inclose proximity to one another to form a retaining chamber retaining atleast an intermediate segment of the prosthesis in the compressedconfiguration, and in the open position, the first shell and the secondshell are spaced away from one another to allow said intermediatesegment of the prosthesis to move to the expanded configuration, aretractable cuff coupled to a second operable member and movable betweena delivery configuration and a deployed configuration, wherein, in thedelivery configuration, the cuff is fitted over an outer end of theprosthesis to retain the outer end in the compressed configuration forinsertion into the body vessel, and in the developed configuration, thecuff is removed from the outer end of the prosthesis to allow forexpansion thereof, the cuff moving between the delivery and deployedconfigurations when the first and second shells are in the closedposition, the cuff moving from the outer end in the deliveryconfiguration in a direction toward the intermediate segment of theprosthesis in the deployed configuration, and the cuff being splittableinto a first cuff portion associated with the first shell and a secondcuff portion associated with a second shell to allow the first andsecond shell to move to the open position; and wherein, in response tomovement of the second operable member between the first position andthe second position, the cuff moves relative to the first and secondshells between the delivery configuration and the deployedconfiguration, and in response to movement of the first operable memberbetween the first position and the second position, the first and secondshells move relative to one another between the closed position and theopen position.
 2. The deployment system of claim 1, wherein at least oneof the first and second shells is pivotably coupled to the support frameto pivot between the closed and open positions.
 3. The deployment systemof claim 1, wherein each of the first and second shells is configured torotate in response to linear movement of an actuation member.
 4. Thedeployment system of claim 1, further comprising a biasing member tobias the shells in the closed position when the first operable member isin the first position.
 5. The deployment system of claim 1, wherein thesupport frame comprises a tubular housing, and comprising an actuationmember comprising a shaft movable within the tubular housing.
 6. Thedeployment system of claim 5, wherein the actuation member comprises anend portion to slidably engage surfaces of the first and second shellsto rotate the shells between the open and closed positions.
 7. Thedeployment system of claim 5, further comprising a pin, and at least oneof the first and second shells comprises an opening formed therein toreceive the pin, wherein, in response to movement of the shaft of theactuation member between the first and second positions, the pin engagedwith the opening causes the shells to rotate between the open and closedpositions.
 8. The deployment system of claim 7, wherein the actuationmember has a distal end having U-shaped body, wherein the pin isextended across the distal end, wherein the first and second shells andthe cuff is rotatable about the pin.
 9. The deployment system of claim1, further comprising a release member associated with the cuff, therelease member coupled to the second operable member and movablerelative to the support frame between a first position and a secondposition, wherein in the first position, a distal end of the releasemember engages the cuff to retain the cuff over the outer end of theprosthesis, and in the second position, the distal end of the releasemember is removed from engagement with the cuff to allow the cuff to beremoved from the outer end of the prosthesis to allow for expansion ofthe outer end.
 10. The deployment system of claim 9, further comprisinga biasing member to bias the cuff away from covering the outer end ofthe prosthesis when the release member is in the second position. 11.The deployment system of claim 1, further comprising another of theretractable cuff and another of the second operable member coupledthereto, the another cuff being fitted over an outer end of theprosthesis opposite of the cuff.
 12. The deployment system of claim 1,wherein the support frame is oriented oblique or substantiallyperpendicular to an axis of the prosthesis.
 13. The deployment system ofclaim 1, wherein the support frame is oriented substantiallyperpendicular to the axis of the prosthesis.
 14. The deployment systemof claim 1, further comprising a track, the cuff sliding along the trackbetween the delivery and deployed configurations.
 15. The deploymentsystem of claim 1, wherein the cuff comprises a radial flange sizedgreater than the body vessel, the flange stopping insertion of the cuffinto the body vessel to control an insertion distance.
 16. Thedeployment system of claim 1, wherein the cuff has a tapered outersurface to facilitate insertion into the body vessel.
 17. The deploymentsystem of claim 1, wherein each of the first and second shells isconfigured to rotate in response to linear movement of an actuationmember, and further comprising another of the retractable cuff andanother of the second operable member coupled thereto, the another cuffbeing fitted over an outer end of the prosthesis opposite of the cuff.18. The deployment system of claim 17, wherein the support frame isoriented oblique or substantially perpendicular to an axis of theprosthesis.
 19. the deployment system of claim 18, further comprising atrack, the cuffs sliding along the track between the delivery anddeployed configuration.
 20. The deployment system of claim 19, whereinthe cuffs have a tapered outer surface to facilitate insertion into thebody vessel.